Pharmaceutical composition comprising an anti-cd6 monoclonal antibody used in the diagnosis and treatment of rheumatoid arthritis

Abstract

The present invention is related to the branch of immunology and particularly with the generation of pharmaceutical compositions containing a humanized monoclonal antibody recognizing the leukocyte differentiation antigen CD6. Accordingly with that statement, the purpose of this invention is to provide pharmaceutical compositions which contain a humanized anti-CD6 monoclonal antibody for the diagnosis and treatment of Autoimmune Diseases, particularly the Rheumatoid Arthritis.

That which is claimed is: 
     
         1 . A method of treating Rheumatoid Arthritis in a subject thereof, the method comprising administering to the subject an anti-CD6 monoclonal antibody, wherein the anti-CD6 monoclonal antibody is humanized IOR-T1h that is produced by hybridoma IOR-T1a disposited with ECACC as deposit No. ECACC 96112640 and wherein the anti-CD6 is in a therapeutic amount to reduce painful and swollen joints. 
     
     
         2 . The method of  claim 1 , wherein the therapeutic amount is in the range from 0.05 to 1 mg/Kg of body weight. 
     
     
         3 . The method of  claim 2 , wherein the therapeutic amount is in the range from 0.2 to 0.8 mg/Kg of body weight. 
     
     
         4 . The method of  claim 1 , further comprising a chemotherapeutic agent, a specific monoclonal antibodies against T and B lymphocytes surface molecules, or a cytokine. 
     
     
         5 . The method of  claim 4 , wherein the monoclonal antibody against T and B lymphocytes surface molecules is an anti-CD20 antibody. 
     
     
         6 . The method of  claim 4 , wherein the chemotherapeutic agent is Methotrexate. 
     
     
         7 . The method of  claim 4 , wherein the cytokine is the Tumor Necrosis Factor alpha. 
     
     
         8 . The method of  claim 1 , wherein the antibody is included in a composition comprising an appropriate excipient. 
     
     
         9 . The method of  claim 1 , wherein the antibody is administered daily for six weeks. 
     
     
         10 . The method of  claim 1  wherein the antibody is administered by injection.